A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors

NCT04476641 | Unknown Phase 2 DMC

• 1 other identifier: B2016-036-02
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

Brief Summary

Main purpose of this study is through comparing with the external control, evaluation of autologous D - CIK cells immunotherapy to finish after conventional treatment of liver cancer, renal clear cell carcinoma and nasopharyngeal carcinoma, lung cancer, colon cancer, breast cancer patients with the clinical efficacy and safety of study population, including clinical liver, renal clear cell carcinoma and nasopharyngeal carcinoma, lung cancer, colon cancer, breast cancer after conventional treatment (surgery, chemotherapy and radiotherapy) patients.The primary outcome measures were overall survival and progression-free survival, while the secondary outcome measures were overall response rate and quality of life.

Conditions

Liver Cancer; Kidney Cancer; Nasopharyngeal Cancer; Lung Cancer; Colorectal Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• OS and PFS

  Overall survival and progression-free survival

  The enrollment period was 3 years and the follow-up period was 5 years

Secondary Outcomes (1)

• ORR, CR+PR

  The enrollment period was 3 years and the follow-up period was 5 years

Study Arms (1)

DC-CIK

EXPERIMENTAL

Other: CELL

Interventions

CELL OTHER

inject the DC-CIK(dendritic cell activated and cytokine induced killer cell)

DC-CIK

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Patients diagnosed with liver cancer, renal clear cell carcinoma, nasopharyngeal carcinoma, lung cancer, colorectal cancer, breast cancer and nasopharyngeal carcinoma by imaging examination, tissue and/or cytology, and patients after conventional treatment (surgery, chemotherapy and radiotherapy); (2) No history of other tumors (except surgically cured skin squamous cell carcinoma).
• (3) Male or female, aged over 18 and under 75 (including 18 and 75 years old). (4) Physical condition: ECOG score 0 or 1. (5) Expected survival time ≥ 6 months, and follow-up was available. (6) Within 7 days before the start of treatment, the results of blood routine, liver and kidney function, and hemagglutination laboratory examination meet the following standards:White blood cell (WBC) ≥ 3.5×109/L, platelet (PLT) ≥ 80×109/L, Neutropene (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90g/L, aspartic acid transaminase (AST) \< 2.5× normal upper limit (ULN) (liver metastasis \< 5×ULN), alanine transaminase (ALT) \< 2.5×ULN (liver metastasis \< 5×ULN), total bilirubin (TIBC) \< 1.5×ULN,Serum creatinine (CR) \< 1.0×ULN, prothrombin time, partial thrombin time, plasma fibrinogen, thrombin time were within the normal range.
• (7) Female subjects must use effective contraceptives (such as prescription oral contraceptives, injectable contraceptives, iUDS, double blocking, contraceptive patch, male partner sterilization, etc.) throughout the study period;Serum or urine pregnancy test results must be negative during screening and throughout the study period.
• (8) Male subjects should take effective contraceptive measures within 1 month after receiving treatment and completing chemotherapy.
• (9) Be willing to comply with the prohibitions and restrictions stipulated in the research plan.
• (10) The subjects have signed an informed consent, stating that they understand the purpose, procedure and content of the study and are willing to participate in the study.

You may not qualify if:

• (1) Patients with clinical symptoms of brain metastasis (except after radiotherapy).
• (2) There is an active viral or bacterial infection that cannot be controlled with appropriate anti-infective therapy.
• (3) Known to be serologically positive for HIV, syphilis, active HBV or HCV infection.
• (4) Having a mental illness or other medical condition, such as uncontrollable heart or lung disease, diabetes, etc., and failing to comply with the requirements of research treatment and monitoring.
• (5) Those who are known to be allergic to any component in cultured D-CIK cells.
• (6) Active rheumatic diseases. (7) Organ transplanters. (8) Poor compliance. (9) Women during pregnancy. (10) Lactating women.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Kidney Neoplasms; Nasopharyngeal Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianchuan Xia

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Jianchuan Xia, doctor

CONTACT

02087343404

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 20, 2020
• Study Start: May 6, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)